Details for New Drug Application (NDA): 203385
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NDA 203385 describes DACTINOMYCIN, which is a drug marketed by Am Regent, Eugia Pharma, Hikma, Hisun Pharm Hangzhou, Meitheal, and Xgen Pharms, and is included in six NDAs. It is available from four suppliers. Additional details are available on the DACTINOMYCIN profile page.
The generic ingredient in DACTINOMYCIN is dactinomycin. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
The generic ingredient in DACTINOMYCIN is dactinomycin. There are three drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
Summary for 203385
| Tradename: | DACTINOMYCIN |
| Applicant: | Eugia Pharma |
| Ingredient: | dactinomycin |
| Patents: | 0 |
Pharmacology for NDA: 203385
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 203385
Suppliers and Packaging for NDA: 203385
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385 | ANDA | Eugia US LLC | 55150-431 | 55150-431-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385 | ANDA | Eugia US LLC | 55150-928 | 55150-928-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-928-02) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/VIAL | ||||
| Approval Date: | Nov 9, 2017 | TE: | AP | RLD: | No | ||||
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